MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9271
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located, and il was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd maxzero multi-fuse extension set with needleless connector had leakage.The following information was provided by the initial reporter: tpn noted to be leaking at distal end of filter on the "microbore bi-fuse extension set, 2 iv connectors, filter" piece.Quantity affected: 1 ea.Was there injury? no - resulted in the need for increased monitoring.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual inspection of the sample indicates no damages or abnormalities.Priming was attempted on the sample and a leak was immediately identified at the outlet side port of the filter to the assembly tubing.The customer complaint of leakage was confirmed.The investigation was forwarded to manufacturing for root cause analysis.After the investigation it was determined that the root cause for leakage between tubing and filter could be related to lack of solvent in the engagement due to issues with the solvent dispenser.A quality notification was created to address the leakage between the tubing and filter.Additionally, a work order was created to review the solvent dispensers, a quality alert for the specific was communicated to the production personnel, and the work instruction was updated to replace the mdgn solvent dispenser for the medica 7 solvent dispenser to avoid defects due to the incorrect amount of solvent applied between components.A device history record review for model mz9271 lot number 24039019 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23285363
• Report Number: 9616066-2025-03034
• Device Sequence Number: 18331526
• Product Code: FPA
• UDI-Device Identifier: 10885403240744
• UDI-Public: (01)10885403240744(11)240301(17)270301(10)24039019
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: MZ9271
• Device Lot Number: 24039019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown